Women Overcoming and Managing Adversity Now (WOMAN) Study (WOMAN)

The goal of the study is to evaluate the efficacy of a two therapeutic models designed to enhance women's skills for managing reactive emotions in their current lives as well as to educate them about how using these skills can enhance their personal effectiveness and help them to gain control of post-traumatic stress reactions. The interventions adaptations of a manualized psychotherapy that has shown promise with adults with complex Posttraumatic Stress Disorder (PTSD) (Trauma Affect Regulation: Guide for Education and Therapy; TARGET) compared to a supportive group therapy (SGT) that has been found to have modest benefits with women survivors of childhood abuse (Wallis, 2002).

Study Overview

• Status: Completed
• Conditions: PTSD; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: TARGET; Behavioral: SGT

Detailed Description

In a randomized treatment design, we will compare offenders receiving skills-based intervention (TARGET) and those receiving a similar amount of supportive intervention (SGT). We will assess the efficacy of treatment by determining if those receiving the TARGET skills training show an improvement in functionality, as compared to those receiving only supportive intervention. We will measure this by analyzing PTSD symptoms, psychological distress, psychosocial functioning, and social/legal adjustment and services using structured interviews, self-report questionnaires and qualitative questions. Questionnaires are listed below in the outcome measure's section. We will collect follow-up data on program participants who successfully finish the program at York. For those offenders who discharge into the community directly from York, we will collect follow-up data on program participants through CDOC Parole or Probation records. Statistically we anticipate a medium effect size difference between the treatment conditions.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Niantic, Connecticut, United States, 06357
      • York Correctional Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Incarcerated, release not expected within 6 months
• Probable PTSD on PC-PTSD screen and PTSD by CAPS interview

Exclusion Criteria

• Clinically significant psychopathy (PCL-SV severe range)
• Unable to comprehend study materials (Mini-Mental Status Exam Orientation, Attention, and Recall sections total score <15).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TARGET; 12-session affect regulation therapy for PTSD	Behavioral: TARGET; 12-session group therapy twice weekly 6 weeks
Active Comparator: SGT; 12 session supportive group therapy	Behavioral: SGT; 12 sessions supportive group therapy twice weekly 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD	PTSD symptom severity, Clinician Administered PTSD Scale	Post-therapy (within 2 weeks)
PTSD	PTSD symptom severity, Clinician Administered PTSD Scale	3-4 Month Post-therapy Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion Regulation	Negative Mood Regulation Scale	Post-therapy (within 2 weeks)
Trauma-related symptoms	Trauma Symptom Inventory (TSI; Briere, 1995). The TSI is a reliable and validated 100-item measure that generates composite scores for trauma (PTSD symptoms), self (self-regulation problems), and dysphoria (depression, anxiety, anger symptoms).	Post-therapy (within 2 weeks)
Mental health symptoms, well-being, and self-harm	CORE-OM is a 34-item self-report measure reliably and validly assessing current psychiatric symptom severity, risk of harm to self or others, social functioning, and subjective well being	Post-therapy (within 2 weeks)
Emotion Regulation	Negative Mood Regulation Scale	3-4 Month Post-therapy Follow-up
Trauma-related Symptoms	Trauma Symptom Inventory	3-4 Month Post-therapy Follow-up
Mental health symptoms, well-being, and self-harm	CORE-OM 34-item questionnaire	3-4 Month Post-therapy Follow-up

Collaborators and Investigators

• Sponsor: UConn Health
• Investigators: Principal Investigator: Julian D Ford, Ph.D., Uconn Health

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: September 23, 2010
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Estimate): March 29, 2011
• Last Update Submitted That Met QC Criteria: March 28, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: PTSD; Women; Group Therapy; Incarceration
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 09009-2; 2009-DD-BX-0003 (Other Grant/Funding Number: Department of Justice)